Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation
Completed
Vertex Pharmaceuticals Incorporated
Phase 2
2010-10-01
The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and
pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with
ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the
F508del-CFTR mutation.
A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects
Completed
Vertex Pharmaceuticals Incorporated
Phase 1
2013-01-01
The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin,
itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with
ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with
ivacaftor on lung function.
A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
Completed
Vertex Pharmaceuticals Incorporated
Phase 3
2013-05-01
The primary objective of the study was to evaluate the efficacy of lumacaftor in combination
with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF)
who are homozygous for the F508del mutation on the CF transmembrane conductance regulator
(CFTR) gene.
A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
Completed
Vertex Pharmaceuticals Incorporated
Phase 3
2013-04-01
The primary objective of the study was to evaluate the efficacy of lumacaftor in combination
with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF)
who are homozygous for the F508del mutation on the CF transmembrane conductance regulator
(CFTR) gene.
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